System and method for identifying a medical container

ABSTRACT

A wireless identification system and method used for identifying medical vials having a metallic crimp includes an RFID tag having a first antenna element located at the crimp so as to be capacitively coupled to the crimp to increase the effective surface area of the RFID antenna, and a second antenna element mounted to the side of the vial between the ends of the labeling mounted on the vial so as to not mask any visually readable information of the labeling. Dielectric adhesive is used in one embodiment to couple the antenna element to the crimp. The invention is particularly useful for small vials. A manufacturing method in which the wireless tag is an integral part of the container is disclosed.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.14/142,610, filed Dec. 27, 2013, now U.S. Pat. No. 9,589,226, and claimsthe benefit of U.S. Provisional Application No. 61/747,197, filed Dec.28, 2012, all of which are incorporated herein by reference.

BACKGROUND

The invention relates generally to applying radio frequencyidentification (RFID) tags to items, and in particular, to applying RFIDtags to medication containers so that the RFID tag is not obtrusive,does not obscure the text labeling of the container, and functions withthe closure.

There are a number of ways of identifying and tracking articlesincluding visually, optically (bar coding, for example), magnetically,RFID, weighing, and others. Where an automatic system for tracking isdesired, RFID is a candidate since identification data may be obtainedwirelessly. RFID tags have decreased in cost, which has made them evenmore attractive for such an application.

Radio-frequency identification (“RFID”) is the use of electromagneticenergy (“EM energy”) to stimulate a responsive device (known as an RFID“tag” or transponder) to identify itself and in some cases, provideadditionally stored data. RFID tags typically include a semiconductordevice commonly called the “chip” on which are formed a memory andoperating circuitry, which is connected to an antenna. Typically, RFIDtags act as transponders, providing information stored in the chipmemory in response to a radio frequency (“RF”) interrogation signalreceived from a reader, also referred to as an interrogator. In the caseof passive RFID devices, the energy of the interrogation signal alsoprovides the necessary energy to operate the RFID device.

RFID tags may be incorporated into or attached to articles to betracked. In some cases, the tag may be attached to the outside of anarticle with adhesive, tape, or other means and in other cases, the tagmay be inserted within the article, such as being included in thepackaging, located within the container of the article, or sewn into agarment. The RFID tags are manufactured with a unique identificationnumber which is typically a simple serial number of a few bytes with acheck digit attached. This identification number is incorporated intothe tag during manufacture. The user cannot alter thisserial/identification number and manufacturers guarantee that eachserial number is used only once. This configuration represents the lowcost end of the technology in that the RFID tag is read-only and itresponds to an interrogation signal only with its identification number.Typically, the tag continuously responds with its identification number.Data transmission to the tag is not possible. These tags are very lowcost and are produced in enormous quantities.

Such read-only RFID tags typically are permanently attached to anarticle to be tracked and, once attached, the serial number of the tagis associated with its host article in a computer data base. Forexample, a particular type of medicine may be contained in hundreds orthousands of small vials. Upon manufacture, or receipt of the vials at ahealth care institution, an RFID tag is attached to each vial. Each vialwith its permanently attached RFID tag will be checked into the database of the health care institution upon receipt. The RFIDidentification number may be associated in the data base with the typeof medicine, size of the dose in the vial, and perhaps other informationsuch as the expiration date of the medicine. Thereafter, when the RFIDtag of a vial is interrogated and its identification number read, thedata base of the health care institution can match that identificationnumber with its stored data about the vial. The contents of the vial canthen be determined as well as any other characteristics that have beenstored in the data base. This system requires that the institutionmaintain a comprehensive data base regarding the articles in inventoryrather than incorporating such data into an RFID tag.

An object of the tag is to associate it with an article throughout thearticle's life in a particular facility, such as a manufacturingfacility, a transport vehicle, a health care facility, a pharmacystorage area, or other environment, so that the article may be located,identified, and tracked, as it is moved. For example, knowing wherecertain medical articles reside at all times in a health care facilitycan greatly facilitate locating needed medical supplies when emergenciesarise. Similarly, tracking the articles through the facility can assistin generating more efficient dispensing and inventory control systems aswell as improving work flow in a facility. Additionally, expirationdates can be monitored and those articles that are older and about toexpire can be moved to the front of the line for immediate dispensing.This results in better inventory control and lowered costs.

RFID tags may be applied to containers or articles to be tracked by themanufacturer, the receiving party, or others. In some cases where amanufacturer applies the tags to the product, the manufacturer will alsosupply a respective data base file that links the identification numberof each of the tags to the contents of each respective article. Thatmanufacturer supplied data base can be distributed to the customer inthe form of a file that may easily be imported into the customer'soverall data base thereby saving the customer from the expense ofcreating the data base manually. It has been noted that where thecustomer must create the data base, a manual method is often used. Thecustomer's employee reads the RFID device identification and oncereceived at the employee's computer, then manually types the data on thecontainer into the computer data base associating it with the RFIDdevice's identification. Such manual entry of data can result in ahigher incidence of errors.

Many RFID tags used today are passive in that they do not have a batteryor other autonomous power supply and instead, must rely on theinterrogating energy provided by an RFID reader to provide power toactivate the tag. Passive RFID tags require an electromagnetic field ofenergy of a certain frequency range and certain minimum intensity inorder to achieve activation of the tag and transmission of its storeddata. Another choice is an active RFID tag; however, such tags requirean accompanying battery to provide power to activate the tag, thusincreasing the expense and the size of the tag and making themundesirable for use in a large number of applications.

Depending on the requirements of the RFID tag application, such as thephysical size of the articles to be identified, their location, and theability to reach them easily, tags may need to be read from a shortdistance or a long distance by an RFID reader. Such distances may varyfrom a few centimeters to ten or more meters. Additionally, in the U.S.and in other countries, the frequency range within which such tags arepermitted to operate is limited. As an example, lower frequency bands,such as 125 KHz and 13.56 MHz, may be used for RFID tags in someapplications. At this frequency range, the electromagnetic energy isless affected by liquids and other dielectric materials, but suffersfrom the limitation of a short interrogating distance. At higherfrequency bands where RFID use is permitted, such as 915 MHz and 2.4GHz, the RFID tags can be interrogated at longer distances, but theyde-tune more rapidly as the material to which the tag is attachedvaries. It has also been found that at these higher frequencies, closelyspaced RFID tags will de-tune each other as the spacing between tags isdecreased.

The read range (i.e., the range of the interrogation and/or responsesignals) of RFID tags is limited. For example, some types of passiveRFID tags have a maximum range of about twelve meters, which may beattained only in ideal free space conditions with favorable antennaorientation. In a real situation, the observed tag range is often sixmeters or less. In addition to the above, the detection range of theRFID systems is typically limited by signal strength to short ranges,frequently less than about thirty centimeters for 13.56 MHz systems.Therefore, portable reader units may need to be moved past a group oftagged items in order to detect all the tagged items, particularly wherethe tagged items are stored in a space significantly greater than thedetection range of a stationary or fixed single reader antenna.Alternately, a large reader antenna with sufficient power and range todetect a larger number of tagged items may be used. However, such anantenna may be unwieldy and may increase the range of the radiated powerbeyond allowable limits. Furthermore, these reader antennae are oftenlocated in stores or other locations where space is at a premium and itis expensive and inconvenient to use such large reader antennae. Inanother possible solution, multiple small antennae may be used but sucha configuration may be awkward to set up when space is at a premium andwhen wiring is preferred or required to be hidden.

In the case of medical supplies and devices, it is desirable to developaccurate tracking, inventory control systems, and dispensing systems sothat RFID tagged devices and articles may be located quickly should theneed arise, and may be identified for other purposes, such as expirationdates or recalls. Automated dispensing cabinets (“ADC”) and similarcabinets used in a health care facility exist where the contents of thedrawers of the cabinet need to be tracked; i.e., inventoriedperiodically. A large number of medical items, devices, and articles arelocated closely together in the drawers. RFID tracking systems formedications do exist and have been found to be particularly helpful inautomating medication inventorying and tracking in medical facilities.One such system is the Intelliguard System from MEPS Real-Time, Inc. ofCarlsbad, Calif.

Glass vials ranging in size from 1 ml to 50 ml used in thepharmaceutical industry to store liquid and powder medication canpresent challenges to RFID tagging due to their small size, metal cap,and FDA required product labeling. Small glass vials are usedextensively in the US pharmaceutical industry. These vials can be assmall as 0.625 inches (15.875 mm) in diameter and 1.25 inches (31.75 mm)tall. Liquid medication is generally stored in these vials; however,medication in powder form can also be stored in the vials.

These small vials are used to store as little as 1 ml and up to morethan 100 ml of liquid medication. The glass vial is capped by acombination of rubber and metal materials. The rubber component servestwo purposes:

-   -   1. The rubber material presses against the glass of the vial to        form a seal that prevents the liquid from escaping the vial; and    -   2. An exposed area of rubber in the top of the cap provides        access to the medication via a sharpened cannula or needle of a        syringe for example.        The metal portion, or “crimp,” of the cap presses the rubber        material against the glass vial to safely secure the cap onto        the vial.

Tracking a very small glass medication vial, such as a 1 ml vial, with aUHF RFID tag is a challenge. This is principally due to the fact thatmost RFID tags operating in the United States in the UHF 915 MHzIndustrial, Scientific, and Medical bands (“ISM”) are too large in sizefor attachment to the small vials. The small near-field tags that aretypically attached to the bottom of the smallest vial have a very shortread distance and can be rendered non-functional when stacked on top ofthe metal cap of an adjacent vial.

The performance of current RFID tracking tags, placed on or near themedication vial metal cap, is greatly reduced due to detuning of theRFID tag antenna. The best current method for tracking small medicationvials, using UHF RFID technology, requires the placement of a smallround (0.3 inch or 7.62 mm diameter) “near-field” tag on the bottom ofthe vial, as mentioned above. (Note—the term “near field” is used torefer to a UHF RFID tag that has been optimized for harvesting thenear-field magnetic energy transmitted from a UHF antenna. These“near-field” tags exhibit very short read distances (6 to 12 inches or15.24 to 30.48 mm) but are less susceptible to detuning from liquidscontained in the items being tracked). The “near-field” UHF tags performbest when positioned parallel to a UHF transmit antenna which has alsobeen optimized for “near-field” transmission. This orientationlimitation requires that all medication vials be standing straight up,with the tags parallel to the antenna, in order that they be accuratelyand repeatedly identified. If a medication vial is in a differentorientation, chances of accurate detection are lessened. The currentRFID tag employed for UHF tracking medication vials can only be easilyidentified in one orientation (parallel to the transmit antenna). Theperformance of current RFID tracking tags, placed on or near themedication vial metal cap, is greatly reduced.

Containers containing prescription medications are also subject to FDArequired labeling. The FDA regulations (21 CFR §610.60) for containerlabels include the need to place certain information on the label. Inparticular, the following items shall appear on the label affixed toeach container of a product capable of bearing a full label:

(1) The proper name of the product;

(2) The name, address, and license number of manufacturer;

(3) The lot number or other lot identification;

(4) The expiration date;

(5) The recommended individual dose for multiple dose containers;

(6) The statement: “Rx only” for prescription biologicals; and

(7) A Medication Guide, if required.

If the container is capable of bearing only a partial label, thecontainer shall show as a minimum the name (expressed either as theproper or common name), the lot number or other lot identification andthe name of the manufacturer; in addition, for multiple dose containers,the recommended individual dose. Containers bearing partial labels shallbe placed in a package which bears all the items required for a packagelabel.

Such “labels” may consist of a physical base material on which is formeda principal display panel (“PDP”), which is defined by the FDA as “thepanel of a label that is most likely to be displayed, presented, shown,or examined by the end user.” In most cases there is a border on thelabel material surrounding the PDP that contains no information. Thelabel may be attached to the medication container through various means,one of which is with adhesive. For the purposes of this application,when referring to a label the inventor intends to mean the PDP. In mostcases, the base material does not completely surround the side of thecontainer so that one end of the label meets the other end when it ismounted. Usually, there is space between the ends of the label when itis mounted to the vial or container. But in most cases, there is spacebetween the ends of the PDP when the base material of the label ismounted to the container, as is shown in FIG. 1.

Referring now to FIG. 1 with more particularity, a typical label basematerial 35 is mounted to a medication container or vial 30. The PDP onthis label base material is indicated by numeral 36. The ends 40 and 42of the label base material do not meet when the label is applied to thecontainer and there is space 44 between the ends of the base material.There is therefore also space between the ends 38 and 39 of the PDPsince the PDP is part of and is smaller than the base material. In caseswhere the base material ends meet when the label is applied to acontainer, the ends of the PDP may still have space between them on thecontainer. As will be discussed below, this space between the ends ofthe PDP is used to mount an RFID device permanently to the container toenable wireless identification of the container by RF energy. Inparticular, an RFID system is described.

The label PDP is shown in FIG. 1 having dashed lines on it which aremeant to indicate visually readable information. This usually includestext, such as drug identification and concentration, and may alsoinclude other information. Information on the PDP may also includegraphic or non-text information. In the case of FIG. 1, a bar code 48 isalso included near the closed end of the container.

Turning now to FIG. 2, there is a typical glass container or vial 34having an opening 46 at the top 50 directly opposite a closed end 52(shown in FIG. 1), a rubber stopper 47, and a crimp closure 32 having anopening 33 formed therein so that the stopper is accessible topenetration by a cannula for extraction of the item in the container, orfor adding to the item in the container. As is well know to those ofskill in the art, the crimp closure is used to secure the stopper inplace at the opening of the container to seal the container.

Turning now to FIG. 3, a prior art “flag tag” identification system 56is shown. In this view, the medical item container 30 is small in sizeand in this case is a 1 ml vial. There is a metallic crimp closure 32around a rubber stopper (not shown) with the crimp closure having anopening 33 at the top through which a cannula may be used to interactwith the medical item within the vial. The “flag tag” 56 is actually anRFID device 57 mounted to a substrate 58 that is flexible. The substrateis then taped 59 to the vial 30. The width of the substrate and tape isapproximately equal in this case to the barrel portion 64 of the vial,due to the small size of the vial. In most cases, clear tape is used toattach the RFID device to the vial so that the visual information on thelabel 65 can be read through the tape. The RFID device 57 includes inthis case a circuitry element 66 containing a memory and processor andother components, and first 67 and second 68 antenna elements. The twoantenna elements provide two poles for this RFID device. Other antennaarrangements are possible, as is discussed below in more detail.

“Flag tag” RFID systems are used typically because the particular vialsize is too small for mounting the RFID device on it. The flag tag ismanually taped to the vial over the labeling and the identificationnumber of the RFID tag is read into a data base for the medical itemwithin the vial to which the tag is attached. The flag tagged medicalitem container can then be put into the medication “stream” within afacility and can be tracked by means of its associated RFID device.However, disadvantages exist. Such flag tags can inadvertently be pulledoff the vial because they are fairly large and extend outward from thevial in a flag style. Gripping them by the substrate may cause the flagtag to pull off of the vial. They can be difficult to handle because ofthe flexibility of the RFID substrate, which may interact with flag tagsof other small vials interfering with the orderly stocking of the vialsin a drawer or other storage unit. When put into drawers of a storagedevice, such as an ADC, the flag tag can be torn from the medicationvial by catching of the door or frame hardware.

Hence, a need has been recognized in the art for a wirelessidentification system that is useful for small medical item containerswhere the identification system is a part of the container and providesaccurate detection and identification of the container. A need has alsobeen recognized for an identification system that can be mounted to amedical item container that does not mask visually readable informationof the labeling of the container. A further need has been recognized foran identification system that is small in size yet provides an antennasurface area large enough for accurate identification. The inventionfulfills these needs and others.

SUMMARY OF THE INVENTION

An RFID tag in accordance with aspects of the invention operates withthe metal closures of medication containers to provide improved locationidentification operation and at the same time, avoid obscuring the textand bar code labeling on the container. The resulting RFID tag can thenbe more accurately identified in multiple orientations.

Briefly, and in general terms, the invention is directed to a system foridentifying a medical container, the container having a size selected tohold a medical item and having an opening at one end, the systemcomprising a metallic closure located at the opening of the container, awireless identification tag comprising a first antenna element and a tagcircuitry element, the tag circuitry element including a memory and aprocessor, the tag circuitry element being connected to the antennaelement, the tag circuitry element configured to receive aninterrogation signal through the antenna element and to transmit aresponse identification signal to the interrogation signal through theantenna element, wherein the response identification signal isassociated with a medical item held by the medical container to identifythe held item, wherein the first antenna element is electricallyconnected to the metallic closure of the container thereby increasingthe effective surface area of the antenna with the metallic closure.

In more detailed aspects, the system for identifying a medical containerfurther comprises an electrically resistant seal located between themetallic closure and the item contained by the medical container wherebythe seal provides electrical insulation to the medical item held by themedical container from the electrically conductive metal closure. Thesystem for identifying a medical container further comprises adielectric element located between the first antenna element and themetallic closure with the antenna element contacting the dielectricelement on one side of the dielectric element and the metallic closureof the medical container contacting the dielectric element on anopposite side of the dielectric element from the antenna element,whereby the antenna element is capacitively coupled to the metalliccontainer closure. In yet a further detailed aspect, the dielectricelement comprises adhesive located on either side of the dielectricelement whereby the first antenna element is held by adhesive to oneside of the dielectric element and the metallic closure is held byadhesive to an opposite side of the dielectric element from the antennaelement, whereby the antenna element is capacitively coupled to themetallic container closure.

In other more detailed aspects, the system for identifying a medicalcontainer further comprises a second antenna element also connected tothe circuitry element through which an interrogation signal is receivedand an identification response signal is transmitted, wherein the secondantenna element is located along a side of the medical container at aposition that does not mask any visually-readable labeling of thecontainer. The medical container also includes a label located aroundthe container, the label having visually readable information concerningthe contents of the container and also having two ends separated fromeach other by a space, wherein the second antenna element is located inthe space between the two label ends.

In additional detailed aspects, the first antenna element is directlyelectrically connected to the metallic closure and the system furthercomprises an electrically resistant seal located between the metallicclosure and the item contained by the medical container whereby the sealprovides electrical insulation to the medical item held by the medicalcontainer from the electrically conductive metal closure.

In another aspect, the system further comprises a second antenna elementalso connected to the circuitry element through which an interrogationsignal is received and an identification response signal is transmitted,wherein the second antenna element is located along a side of themedical container at a position that does not mask any visually-readablelabeling of the container. The medical container includes a labellocated around the container, the label having visually readableinformation concerning the contents of the container and also having twoends separated from each other by a space, wherein the second antennaelement is located in the space between the two label ends.

In another detailed aspect the wireless identification tag comprises anRFID tag and the identification signal comprises a serial number of theRFID tag that has been associated with the identification of thecontents of the medical container.

In method aspects of the subject invention, a method for identifying amedical container is provided, the container having a size selected tohold a medical item and having an opening at one end at which is mounteda metallic closure, the method comprises mounting a wirelessidentification tag comprising a first antenna element and a tagcircuitry element to the container, the tag circuitry element includinga memory and a processor, the tag circuitry element being connected tothe antenna element, the tag circuitry element configured to receive aninterrogation signal through the antenna element and to transmit aresponse identification signal to the interrogation signal through theantenna element, wherein the response identification signal isassociated with a medical item held by the medical container to identifythe held item, and mounting the first antenna element of theidentification tag into electrical connection with the metallic closureof the container thereby increasing the effective surface area of theantenna with the metallic closure.

In more detailed method aspects, the method further comprises sealingthe opening of the medical container with an electrically resistant seallocated between the metallic closure and the item contained by themedical container whereby the seal provides electrical insulation to themedical item held by the medical container from the electricallyconductive metal closure. The method additionally comprises locating adielectric element between the first antenna element and the metallicclosure with the antenna element contacting the dielectric element onone side of the dielectric element and the metallic closure of themedical container contacting the dielectric element on an opposite sideof the dielectric element from the antenna element, whereby the antennaelement is capacitively coupled to the metallic container closure.

In further aspects, the step of locating a dielectric element comprisesattaching the dielectric element to the first antenna element and themetallic closure with dielectric adhesive whereby the antenna element iscapacitively coupled to the metallic container closure. The methodfurther comprises locating a second antenna element that is alsoconnected to the circuitry element through which an interrogation signalis received and an identification response signal is transmitted, alonga side of the medical container at a position that does not mask anyvisually-readable labeling of the container. The step of locating asecond antenna element comprises locating the second antenna element ina space between two ends of a label mounted around the container,wherein the label has visually readable information concerning thecontents of the container that is not masked by the location of thesecond antenna element in the space between the two ends.

A further aspect is directed to a method for manufacturing a medicalcontainer to have an integral wireless identification system, thecontainer having a size selected to hold a medical item and having anopening at one end, the method comprising filling the container with adesired medical item, stopping the opening of the medical container witha sealing material, crimping a metallic closure over the opening of thecontainer and the sealing material to hold the sealing material in placeover the opening to seal the opening, the metallic closure having anopening of a size selected to be large enough through which to insert acannula through that opening and the stopper to access the itemcontained within the medical container, mounting a wirelessidentification tag comprising a first antenna element and a tagcircuitry element to the container, the tag circuitry element includinga memory and a processor, the tag circuitry element being connected tothe antenna element, the tag circuitry element configured to receive aninterrogation signal through the antenna element and to transmit aresponse identification signal to the interrogation signal through theantenna element, wherein the response identification signal isassociated with a medical item held by the medical container to identifythe held item, such that the first antenna element of the identificationtag is mounted in electrical connection with the metallic closure of thecontainer thereby increasing the effective surface area of the antennawith the metallic closure, and applying a label to the container overthe wireless identification tag such that any visually readableinformation on the label can be read.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a typical prior art glass medication containeror vial having a metallic crimp top and labeling along its side, thelabel having a size where the ends of the label base material do notmeet when the label is mounted to the vial. The label is also shown hashaving a principal display panel, “PDP, that contains the visuallyreadable material about the contents of the container and in this case,the container also includes an optically-readable bar code;”

FIG. 2 is an exploded perspective view of a typical arrangement of asealed medical item container that includes a glass vial, a rubberstopper, and a metallic crimp closure that holds the stopper in place inthe opening of the glass vial to seal it;

FIG. 3 is a view of a 1 ml container having an information label mountedto its side, a metallic crimp closure that holds a stopper in place toseal the container, and an RFID device located on a strip of materialthat is attached to the container with clear adhesive tape, the RFIDarrangement referred to as a “flag tag;”

FIG. 4 is an enlarged view of a crimp closure top of a vial surroundedin this embodiment by an upper portion of an RFID antenna element anddielectric and showing the antenna element also mounted along the sideof the vial;

FIG. 5 is a top view of the crimp closure top of a very small vialshowing the metallic crimp closure of the top having an antenna elementof an RFID device with a dielectric located between the antenna elementand the metallic crimp closure located around a substantial portion ofthe crimp closure;

FIG. 6 is a perspective view of an embodiment of mounting an RFIDidentification device to a very small glass medical container inaccordance with aspects of the invention, in which a first element of adipole antenna is located and capacitively coupled to the metallic crimpclosure top, and the RFID circuitry element and a second dipole antennaelement are located along the side of the vial between the ends of theinformation label;

FIG. 7 is a side view of a small medical item container having an RFIDdevice attached thereto showing a first antenna element attached with adielectric adhesive to the metallic crimp cap, and the RFID circuitryand a second antenna element attached to the side of the container;

FIG. 8 is a top view of the container of FIG. 7 showing the firstantenna element attached by dielectric adhesive to the crimp closure;

FIG. 9 is a front view of the container of FIGS. 7 and 8 showing theantenna elements and the RFID circuitry attached to the crimp closureand the side of the container;

FIG. 10 shows the opposite side view of that of FIG. 7 showing the firstantenna element located around the metallic crimp closure of thecontainer with the RFID circuitry and second antenna element locatedalong the side of the container;

FIG. 11 shows an embodiment of an RFID device in accordance with aspectsof the invention usable for mounting to very small containers of medicalitems;

FIG. 12 is a block flow diagram of a manufacturing method in accordancewith aspects of the invention; and

FIG. 13 presents different embodiments of RFID antennas usable with RFIDcircuitry elements on medical item containers.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring again to FIG. 1, there is shown a small sealed glass container30 with a metallic crimp closure 32 fastened to the vial portion 34.Although not visible in the drawing, the crimp closure presses a rubberstopper into contact with the top of the vial to seal it shut. Thedrawing also shows FDA-mandated labeling 36 that almost surrounds theside of the vial 34 but between the two ends 40 and 42 of the label basematerial 35, there is a space 44 of the vial that is not covered withanything. The container is presently readable only by scanning the barcode 48 at the bottom 52 of the vial with a barcode reader. It wouldsatisfy a need identified above if the container could be fitted with awireless identification system readable by RF or other non-opticalfrequency. FIG. 3 shows one way to accomplish this; i.e., the “flag tag”system, but the drawbacks are significant, as discussed above.

Many ADCs and other medical item storage units are used to store medicalvials and include RFID systems that establish energy fields within thedrawer or storage space of the unit to detect and read RFID tags onitems stored there. As with the other stored items that are larger, itis desirable to be able to automatically detect and identify small itemsin these storage units. Small medical item containers do not provideenough space on themselves to mount a standard RFID device due to thefrequencies used. RFID frequencies that are used can require a largersurface area for an antenna than what may fit on the side of a smallvial. While the use of a “flag tag” allows the use of the larger antennain the RFID device, it would be more efficient if the tag were integralwith the small container.

In storage drawers of ADCs for example, an RFID field of energy isestablished to interrogate the RFID tags on items stored there. It hasbeen found that the interrogation energy bounces around in the storagearea and that generally, any metal, such as that found in the metalliccrimp closures of medical vials, can diminish the performance of RFIDdevices nearby by de-tuning them. That metal is a reflector of the RFIDenergy in the EM energy field. In accordance with aspects of the presentinvention, that energy is captured and used to run the RFID device andits communications.

Turning now to FIG. 4, a side schematic view of an RFID antenna element60 capacitively coupled with the metallic crimp closure 32 of a sealedvial 30 is shown. The antenna element 60 includes two electricallyconnected parts. The first is the segment 71 mounted along the side 75of the vial that leads from the RFID circuitry element 66 to themetallic closure 32. The second segment 72 is in direct electricalcontact with the first segment 71 at a right angle and is capacitivelycoupled to the crimp closure 32. The area of capacitively coupling isshown with diagonal lines 62. By being electrically coupled to the crimpclosure, the RFID antenna element 60 effectively increases its surfacearea and is more efficiently operated. By virtue of the metallic crimpclosure, the antenna element now has more energy with which to run thecircuitry element 66 and is a more efficient antenna at the RFIDfrequencies used. In this embodiment, the segments 71 and 72 areseparately labeled with drawing numerals but may in fact be formed ofthe same piece of metal. It will also be noted that the second segment72 makes a “T” formation with the first segment 71 and that it fitsalmost entirely around the circumference of the metallic crimp closure32

FIG. 5 is a top view of the sealed vial 30 of FIG. 4 showing the sealedmetallic crimp closure 32 having an open area 70 through which asharpened cannula may be inserted to access the contents of the vial.The figure also shows the RFID antenna segment 72 capacitively coupledwith the metallic crimp 32. A dielectric material 74 is positionedbetween the antenna element 72 and the metallic crimp 32 to capacitivelycouple the two together thereby enhancing the usefulness of the antenna72 of the RFID device by increasing its surface area to include themetallic crimp closure. In this embodiment, the dielectric takes theform of an adhesive tape that also bonds the antenna element 72 to thecrimp closure 32. One dielectric tape found useful for this purpose isthe 3M 467MP product that contains adhesive 200MP, available from the 3MCompany, Industrial Adhesives and Tapes Division, 3M Center, Building225-3S-06, St. Paul, Minn. 55144-1100, 1-800-223-7427.

Enhancing the surface area of the RFID antenna element 72 bycapacitively coupling it to the metallic closure 32 results in a greaterability to interrogate the RFID element on the medication container 30and will result in less interference between containers in the samespatial storage area. Instead of the metallic crimp closure simplyreflecting electromagnetic (“EM”) energy in the storage drawer or otherunit it is placed in and de-tuning RFID device near it, it is used inaccordance with the invention to conduct that EM energy to the RFIDdevice for its enhanced operation.

FIG. 6 is a perspective view of a sealed vial 80 having a metallic crimpclosure 82 that seals the vial. As in FIG. 5, an opening 88 in the crimpclosure 82 permits a sharpened cannula (not shown) to be insertedthrough the rubber seal 90 of the crimp closure to access the interiorof the vial. Also shown in FIG. 6 is an RFID device 92 having a firstantenna element 98 that is positioned over a portion of the metalliccrimp closure 82 and is capacitively coupled thereto to increase theeffectiveness of the first antenna element 98 and indeed the entireantenna of the RFID device 92. The first antenna element 98 is connectedto the RFID circuitry element 100, which is connected at its oppositeend to a second antenna element 94. The second antenna element islocated along the side 96 of the medical item container in the open areawhere no labeling 87 exists. Because the label 87 in the embodimentshown in FIG. 6 is smaller and its ends 102 and 104 do not touch when itis mounted to the vial, the PDP is not shown.

FIG. 7 presents a different embodiment of an RFID system in accordancewith aspects of the invention, wherein a first antenna element 106 has afirst portion 110 traversing the space between the RFID circuitryelement 108 and the metallic crimp closure 114 and then is attached tothe closure with a dielectric tape 116. The RFID system includes asecond antenna element 94 attached to the RFID circuitry and extendingin the opposite direction from the first antenna element along the side86 thus providing an antenna having two poles for the RFID circuitryelement 108. In the case of the second antenna element 94, it is firmlyattached to the side 86 of the vial 80 by adhesive or other means knownto those skilled in the art. FIG. 8 shows the same RFID system from atop view of the medical item container 80. The metallic crimp closure114 of the container 80 is shown with the first antenna element 112 anda coupling dielectric portion 114 positioned in electrical connectionwith it.

FIG. 9 is a side view of the system of FIGS. 7 and 8 showing the RFIDcircuitry element 108 having a dipole antenna with a first element 106extending to the metallic crimp closure 114 and making electricalcontact with it to increase the surface area of the first antennaelement. A dielectric (not shown) is positioned between the firstantenna element and the metallic crimp closure as shown in FIGS. 7 and8. FIG. 10 also presents a side view of the wireless identificationsystem of FIGS. 7-9 but is the opposite side from that shown in FIG. 7.The first antenna element 106 is seen extending from the RFID circuitryelement 108, to the metallic crimp closure 114 and then extending at aninety degree angle to be located around the crimp closure as shown moreclearly in FIG. 8.

FIG. 11 is a view of the RFID system 130 shown in FIGS. 7-10 with thefirst antenna element 106 with its two segments 110 and 112. The firstportion 110 proceeding from the RFID circuitry element 108 and thesecond portion 112 located at ninety degrees from the first portionforming an “L” shape in this embodiment. The second antenna element 94also connected with the RFID circuitry element 108.

The RFID system in FIGS. 7-10 is shown in exaggerated form so that thevarious components and connections can be more clearly seen. The antennaelements 106 and 94, and the RFID circuitry element 108 are likely to bemuch thinner than shown. Additionally, the manner of using adhesives toattach the RFID system to the container 80 results in an integratednature of the RFID system 130 with the vial 80. Such an arrangement canbe implemented during the manufacturing process to result in a usefuland convenient wireless, non-optical identification system and method.

In particular referring now to FIG. 12, in such a manufacturing processor method 140, the container may be filled 142 with the medical itemdesignated for the container, the stopper 144 and metallic crimp closure146 may be attached to seal the container, the RFID system may be thenmounted 148 to the metallic crimp closure and the side of the container,and then the label may be attached 150 to the container over the RFIDcircuitry element and the second antenna element as needed. If the labelis smaller than the circumference of the container such that there wouldbe an open space between its two ends, the label may be mounted to thecontainer such that the space between the two ends is located at theposition of the RFID system. The above steps of the manufacturingprocess may by implemented in different orders as needed.

FIG. 13 is a diagram of various antenna element arrangements usable inthe RFID systems shown in other figures. Each of the antennas shownincludes a first antenna element 160 and a second antenna element 162with an RFID circuitry element 164 located in between. The numerals areshown on only one of the alternate antenna configurations in FIG. 13 topreserve clarity in the figure. In the case of the RFID system shownwith numerals in FIG. 13, the first antenna element is smaller than thesecond antenna element because it will be dielectrically coupled to theelectrically conductive crimp closure and the closure will provide thenecessary surface area for that pole of the antenna.

There has thus been provided a system and method to mount an RFID deviceto vials, including very small medication vials with very littleunlabeled space left on the vial. The novel system and method of theinvention do not cover any labeling of the vial, and do not require theuse of a protruding flag RFID system. The RFID system and method inaccordance with the invention do not significantly protrude from thevial whatsoever and yet provide the means to automatically detect andtrack the vial regardless of what orientation it may have in relation toa reader antenna. Additionally, since the metallic crimp closure forms apart of the RFID system, adjacent metallic crimp closures of other vialswill not interfere with tracking each vial. This increased electricalperformance of the RFID system permits the containers to be placed indifferent orientations within drawers or other storage units and stillbe detected and identified. Thus there has been provided a new anduseful system and method that provides improved performance for RFIDsystems attached to medication containers having metallic crimpclosures, and is especially useful for smaller containers. Requiredlabeling is still readable and not masked by the new RFID system, yetthe containers may be detected and identified.

In the above detailed description, well-known devices, methods,procedures, and individual components have not been described in detailso as not to obscure aspects of the present invention. Those skilled inthe art will understand those devices, methods, procedures, andindividual components without further details being provided here.Moreover, while the embodiments disclosed above are described for use ina healthcare facility environment, it will be understood that the systemand method may be useful in other environments as well, such asoutpatient clinics, doctors' offices, and other environments.

Further features and/or variations of the invention may be provided inaddition to those set forth herein. For example, the present inventionmay be directed to various combinations and sub-combinations of thedisclosed features and/or combinations and sub-combinations of severalfurther features disclosed below in the detailed description.

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments and elements, but, to the contrary, is intended tocover various modifications, combinations of features, equivalentarrangements, and equivalent elements included within the spirit andscope of the appended claims. The invention may be embodied in otherforms without departure from the spirit, scope, and essentialcharacteristics thereof. The embodiments described therefore are to beconsidered in all respects as illustrative and not restrictive. Althoughthe present invention has been described in terms of certain preferredembodiments and applications, other embodiments and applications thatare apparent to those of ordinary skill in the art are also within thescope of the invention.

1. A system for identifying a medical container, the container having aninternal size selected to hold a medical item within, the containerhaving an outer surface with visually-readable labeling informationappearing on the outer surface, the labeling information pertaining tothe medical item held by the container, the container also having anopening at one end, the system comprising: an electrically conductivecap located at the opening of the container, the cap having an innersurface and an outer surface; an electrically resistant seal locatedbetween the inner surface of the metallic cap and the opening of thecontainer, whereby the seal prevents the medical item from escaping fromthe container and provides electrical insulation between theelectrically conductive cap and the medical item located within themedical container; and a wireless identification tag comprising a firstantenna element electrically connected to a tag circuitry element, thetag circuitry element including a memory and a processor with the tagcircuitry element processor being programmed to receive an interrogationsignal through the first antenna element, to access the tag circuitrymemory to retrieve a tag identification number, and to transmit theretrieved tag identification number in an identification signal inresponse to the interrogation signal through the first antenna element,wherein the response identification signal is associated with a medicalitem held by the medical container to identify the held item; wherein atleast a portion of the first antenna element is electrically connectedto the outer surface of the electrically conductive cap of the containerthereby increasing the effective surface area of the antenna with themetallic closure.
 2. (canceled)
 3. The system for identifying a medicalcontainer of claim 1 further comprising a dielectric element locatedbetween the first antenna element and the electrically conductive capwith the first antenna element contacting the dielectric element on oneside of the dielectric element and the electrically conductive cap ofthe medical container contacting the dielectric element on an oppositeside of the dielectric element from the first antenna element, wherebythe first antenna element is capacitively coupled to the metalliccontainer closure.
 4. The system for identifying a medical container ofclaim 3 further comprising adhesive located on either side of thedielectric element whereby the first antenna element is held by theadhesive to one side of the dielectric element and the metallic closureis held by the adhesive to an opposite side of the dielectric elementfrom the first antenna element, whereby the first antenna element iscapacitively coupled to the electrically conductive cap.
 5. The systemfor identifying a medical container of claim 1 further comprising asecond antenna element also connected to the tag circuitry element, thesecond antenna element also configured to receive an interrogationsignal and to transmit an identification response signal, wherein thesecond antenna element is located along a side of the medical containerat a position that does not mask any of the visually-readable labelinginformation on the container.
 6. The system for identifying a medicalcontainer of claim 5 wherein the medical container includes a labellocated around the container, the label having the visually readableinformation concerning the contents of the container and also having twoends separated from each other by a space; wherein the second antennaelement is located in the space between the two label ends.
 7. Thesystem for identifying a medical container of claim 3 wherein thedielectric element comprises dielectric adhesive located between thefirst antenna element and the cap whereby the dielectric adhesiveprovides both a dielectric element to capacitively couple the firstantenna element to the metallic closure and holds the first antennaelement in position at the cap.
 8. (canceled)
 9. (canceled)
 10. Thesystem for identifying a medical container of claim 1 wherein thewireless identification tag comprises an RFID tag.
 11. The system foridentifying a medical container of claim 1 wherein the electricallyconductive cap has an opening configured to receive a cannula forpiercing the electrically resistant seal to obtain access to the heldmedical item within identification signal comprises a serial number ofthe RFID tag that has been associated with the identification of thecontents of the medical container.
 12. An identification system for amedical item container, the container having an internal size selectedto hold a medical item within and having an opening at one end on whichis mounted a metallic closure, the metallic closure having an innersurface and an outer surface with a top having an opening through whicha cannula may be inserted to access the medical article within the itemcontainer and the closure further having a side portion, the containerfurther having a side on which a label having visually readableinformation concerning the held item is mounted, the identificationsystem comprising: an electrically resistant seal located between theinner surface of the metallic closure and the opening of the container,whereby the seal prevents the medical item from escaping the containerand provides electrical insulation between the electrically conductivemetal closure and the medical item located within the medical container,the seal being formed of a material that may be pierced through theopening on the closure for access to the medical article within thecontainer; an RFID tag comprising a first antenna element, a secondantenna element, and a tag circuitry element connected to both the firstand second antenna elements, the tag circuitry element including amemory and a processor wherein an identification number of the RFID tagis stored in the memory and the processor is programmed to access thememory, retrieve the identification number and transmit theidentification number in an identification signal in response toreceiving an interrogation signal through the first and second antennaelements and to transmit the response identification signal through thefirst and second antenna elements, wherein the response identificationsignal is associated with the medical item held by the medical containerto identify the held item; wherein the first antenna element iselectrically connected to the side portion of the metallic closure ofthe container thereby increasing the effective surface area of theantenna with the metallic closure; and wherein the second antennaelement is mounted to the container and extends along the side of thecontainer at a location that does not mask any visually readableinformation of the labeling.
 13. The identification system of claim 12further comprising a dielectric adhesive located between the firstantenna element and the outer surface of the side portion of themetallic closure wherein the dielectric adhesive holds the first antennaelement in a position on the outer surface of the side portion of themetallic closure, whereby the first antenna element is capacitivelycoupled to the metallic container closure. 14-16. (canceled)
 17. Amethod for identifying a medical container, the container having aninternal size selected to hold a medical item within, and having anouter surface with visually-readable labeling information appearing onthe container's outer surface, the labeling information pertaining tothe medical item held by the container, the container also having anopening at one end at which is mounted a metallic closure, the closurehaving an inner surface and an outer surface, the method comprising:mounting a first antenna element to the metallic closure, the firstantenna element forming a part of a wireless identification tag, thewireless identification tag also comprising a tag circuitry element thatis connected to the first antenna element, the tag circuitry elementincluding a memory and a processor wherein an identification number ofthe wireless identification tag is stored in the memory and theprocessor is programmed to access the memory, retrieve theidentification number, and transmit the identification number in anidentification signal in response to receiving an interrogation signalthrough the first antenna element and to transmit the identificationresponse identification signal through the first antenna element,wherein the response identification signal is associated with a medicalitem located within the medical container to identify the medical item;and mounting a second antenna element that forms a part of the wirelessidentification tag and to which the circuitry element is connected, tothe side of the container at a location that does not mask any of thevisually readable labeling information.
 18. (canceled)
 19. The methodfor identifying a medical container of claim 17 further comprisinglocating a dielectric element between the first antenna element and themetallic closure with the first antenna element contacting thedielectric element on one side of the dielectric element and themetallic closure of the medical container contacting the dielectricelement on an opposite side of the dielectric element from the firstantenna element, whereby the first antenna element is capacitivelycoupled to the metallic container closure.
 20. The method foridentifying a medical container of claim 19 wherein the step of locatinga dielectric element comprises applying a dielectric adhesive betweenthe first antenna element and the metallic closure to hold the firstantenna element in place on the metallic closure and to capacitivelycouple the first antenna element to the metallic closure. 21-23.(canceled)
 24. The system for identifying a medical container of claim 1wherein the first antenna element comprises a first segment that ismounted to the outer surface of the container and is connected to thecircuitry element, and a second segment that is oriented at an angle tothe first segment, wherein the second segment of the first antennaelement is electrically connected to the outside of the cap.
 25. Thesystem for identifying a medical container of claim 24 wherein thesecond segment of the first antenna element is disposed at aninety-degree angle to the first segment of the first antenna element.26. The system for identifying a medical container of claim 24 whereinthe second segment of the first antenna element forms an “L” shape withthe first segment of the first antenna element.
 27. The system foridentifying a medical container of claim 24 wherein the second segmentof the first antenna element forms a “T” shape with the first segment ofthe first antenna element.
 28. The system for identifying a medicalcontainer of claim 1 wherein the cap comprises a top and acylindrically-shaped side portion having an outer surface, wherein thefirst antenna element is located so that it is electrically connected tothe cap at the cap's side portion.
 29. The identification system for amedical item container of claim 12 wherein the first antenna elementcomprises first and a second segments, the first segment having a firstend connected with the RFID tag circuit element and a second end, andthe second segment having a first end connected with the second end ofthe first segment and a second end that is oriented at an angle to thefirst segment; wherein the first segment of the first antenna element isnot attached to the metallic closure; and wherein the second segment ofthe first antenna element is capacitively coupled with the metallicclosure.
 30. The identification system for a medical container of claim29 wherein the second segment of the first antenna element is disposedat a ninety-degree angle to the first segment of the first antennaelement.
 31. The identification system for a medical container of claim29 wherein the second segment forms an “L” shape with the first segmentof the first antenna element.
 32. The identification system for amedical container of claim 29 wherein the second segment forms a “T”shape with the first segment of the first antenna element.
 33. Themethod of identifying a medical container of claim 17 wherein the firstantenna element comprises first and a second segments, the first segmenthaving a first end connected with the wireless tag circuit element and asecond end, and the second segment having a first end connected with thesecond end of the first segment; wherein the step of mounting the secondsegment of the first antenna comprises mounting the second segment at anangle to the first segment; wherein the first segment of the firstantenna element is not attached to the metallic closure; and wherein thesecond segment of the first antenna element is capacitively coupled withthe metallic closure.
 34. The method of identifying a medical containerof claim 33 wherein the step of mounting a second segment of the firstantenna at an angle comprises mounting the second segment at aninety-degree angle to the first segment.
 35. The method of identifyinga medical container of claim 33 wherein the step of mounting the secondsegment of the first antenna at a ninety-degree angle to the firstsegment comprises forming an “L” shape between the first and secondsegments.
 36. The method of identifying a medical container of claim 33wherein the step of mounting the second segment of the first antenna ata ninety-degree angle to the first segment comprises forming a “T” shapebetween the first and second segments.